[{"id":"6280dfa5-ede9-4d89-a587-10249cd79abf","acronym":"AGORA-1","url":"https://clinicaltrials.gov/study/NCT05199051","created_at":"2022-01-20T15:53:56.079Z","updated_at":"2025-02-25T14:02:40.845Z","phase":"Phase 2","brief_title":"A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults with FLT3-ITD Relapse/refractory (R/R) AML","source_id_and_acronym":"NCT05199051 - AGORA-1","lead_sponsor":"Centre Antoine Lacassagne","biomarkers":" FLT3 • CD33","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3-TKD mutation • CD33 positive","tags":["FLT3 • CD33"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3-TKD mutation • CD33 positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • Mylotarg (gemtuzumab ozogamicin)"],"overall_status":"Recruiting","enrollment":" Enrollment 50","initiation":"Initiation: 06/03/2023","start_date":" 06/03/2023","primary_txt":" Primary completion: 03/15/2027","primary_completion_date":" 03/15/2027","study_txt":" Completion: 03/15/2027","study_completion_date":" 03/15/2027","last_update_posted":"2025-02-19"},{"id":"2215a379-2b74-4e43-b073-534f2995d428","acronym":"","url":"https://clinicaltrials.gov/study/NCT06001788","created_at":"2023-08-21T14:08:48.344Z","updated_at":"2025-02-25T15:13:42.778Z","phase":"Phase 1","brief_title":"Safety and Tolerability of Ziftomenib Combinations in Patients with Relapsed/Refractory Acute Myeloid Leukemia","source_id_and_acronym":"NCT06001788","lead_sponsor":"Kura Oncology, Inc.","biomarkers":" FLT3 • NPM1 • KMT2A","pipe":" | ","alterations":" FLT3 mutation • NPM1 mutation • KMT2A rearrangement • KMT2A mutation • MLL mutation","tags":["FLT3 • NPM1 • KMT2A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation • NPM1 mutation • KMT2A rearrangement • KMT2A mutation • MLL mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • idarubicin hydrochloride • Komzifti (ziftomenib) • fludarabine IV"],"overall_status":"Recruiting","enrollment":" Enrollment 171","initiation":"Initiation: 02/22/2024","start_date":" 02/22/2024","primary_txt":" Primary completion: 08/01/2026","primary_completion_date":" 08/01/2026","study_txt":" Completion: 08/01/2027","study_completion_date":" 08/01/2027","last_update_posted":"2025-02-13"},{"id":"460f1e61-72a2-48bb-a37c-e804016f6240","acronym":"NCI-2021-06095","url":"https://clinicaltrials.gov/study/NCT05010122","created_at":"2021-08-18T15:53:42.501Z","updated_at":"2025-02-25T15:12:15.219Z","phase":"Phase 1/2","brief_title":"ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","source_id_and_acronym":"NCT05010122 - NCI-2021-06095","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • Xospata (gilteritinib) • Inqovi (decitabine/cedazuridine)"],"overall_status":"Recruiting","enrollment":" Enrollment 42","initiation":"Initiation: 07/08/2021","start_date":" 07/08/2021","primary_txt":" Primary completion: 01/30/2026","primary_completion_date":" 01/30/2026","study_txt":" Completion: 01/30/2026","study_completion_date":" 01/30/2026","last_update_posted":"2025-02-13"},{"id":"99225106-dfaa-4574-8f8a-c62a8252d206","acronym":"","url":"https://clinicaltrials.gov/study/NCT04293562","created_at":"2021-01-18T20:50:03.431Z","updated_at":"2025-02-25T15:11:29.634Z","phase":"Phase 3","brief_title":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations","source_id_and_acronym":"NCT04293562","lead_sponsor":"Children's Oncology Group","biomarkers":" FLT3","pipe":"","alterations":" ","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Erwinase (erwinia asparaginase) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate) • dexrazoxane"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 1186","initiation":"Initiation: 07/21/2020","start_date":" 07/21/2020","primary_txt":" Primary completion: 09/30/2027","primary_completion_date":" 09/30/2027","study_txt":" Completion: 09/30/2027","study_completion_date":" 09/30/2027","last_update_posted":"2025-02-13"},{"id":"b4e91c3d-4887-4ce6-b858-890536bcbb7b","acronym":"HOVON 156 AML","url":"https://clinicaltrials.gov/study/NCT04027309","created_at":"2021-01-18T19:46:07.637Z","updated_at":"2025-02-25T15:26:07.674Z","phase":"Phase 3","brief_title":"A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy","source_id_and_acronym":"NCT04027309 - HOVON 156 AML","lead_sponsor":"Stichting Hemato-Oncologie voor Volwassenen Nederland","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation • FLT3-TKD mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation • FLT3-TKD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • midostaurin"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 777","initiation":"Initiation: 12/20/2019","start_date":" 12/20/2019","primary_txt":" Primary completion: 10/01/2025","primary_completion_date":" 10/01/2025","study_txt":" Completion: 06/01/2033","study_completion_date":" 06/01/2033","last_update_posted":"2024-12-17"},{"id":"a154a323-d6ef-4152-926e-c4ab1ae75b5e","acronym":"","url":"https://clinicaltrials.gov/study/NCT05756777","created_at":"2023-03-06T15:01:58.629Z","updated_at":"2025-02-25T15:36:05.770Z","phase":"Phase 1","brief_title":"A Study of Gilteritinib in Combination with Ivosidenib or Enasidenib in People with Acute Myeloid Leukemia (AML)","source_id_and_acronym":"NCT05756777","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" FLT3 • IDH1 • IDH2","pipe":" | ","alterations":" IDH1 mutation • IDH2 mutation • FLT3 mutation","tags":["FLT3 • IDH1 • IDH2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e IDH1 mutation • IDH2 mutation • FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • Tibsovo (ivosidenib) • Idhifa (enasidenib)"],"overall_status":"Recruiting","enrollment":" Enrollment 36","initiation":"Initiation: 06/26/2023","start_date":" 06/26/2023","primary_txt":" Primary completion: 02/01/2025","primary_completion_date":" 02/01/2025","study_txt":" Completion: 02/01/2025","study_completion_date":" 02/01/2025","last_update_posted":"2024-11-12"},{"id":"55079916-4788-41a0-a5ca-a4084d122a58","acronym":"","url":"https://clinicaltrials.gov/study/NCT05024552","created_at":"2021-08-27T12:52:57.710Z","updated_at":"2024-07-02T16:34:26.210Z","phase":"Phase 1","brief_title":"Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML","source_id_and_acronym":"NCT05024552","lead_sponsor":"H. Lee Moffitt Cancer Center and Research Institute","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3-TKD mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3-TKD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)"],"overall_status":"Recruiting","enrollment":" Enrollment 22","initiation":"Initiation: 08/23/2021","start_date":" 08/23/2021","primary_txt":" Primary completion: 08/01/2024","primary_completion_date":" 08/01/2024","study_txt":" Completion: 08/01/2025","study_completion_date":" 08/01/2025","last_update_posted":"2024-06-13"},{"id":"1d8c8a20-aa7c-47e4-aa25-c755f938afd8","acronym":"LACEWING","url":"https://clinicaltrials.gov/study/NCT02752035","created_at":"2021-01-17T17:23:14.096Z","updated_at":"2024-07-02T16:34:26.721Z","phase":"Phase 3","brief_title":"A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy","source_id_and_acronym":"NCT02752035 - LACEWING","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3 mutation • FLT3 D835 • FLT3 I836","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation • FLT3 D835 • FLT3 I836"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • azacitidine"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 183","initiation":"Initiation: 08/01/2016","start_date":" 08/01/2016","primary_txt":" Primary completion: 03/10/2023","primary_completion_date":" 03/10/2023","study_txt":" Completion: 06/30/2024","study_completion_date":" 06/30/2024","last_update_posted":"2024-06-12"},{"id":"3d3f57b8-7c54-40f3-80db-21c1598bb35e","acronym":"","url":"https://clinicaltrials.gov/study/NCT02310321","created_at":"2021-01-18T10:56:18.517Z","updated_at":"2024-07-02T16:34:37.261Z","phase":"Phase 1/2","brief_title":"A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.","source_id_and_acronym":"NCT02310321","lead_sponsor":"Astellas Pharma Inc","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • idarubicin hydrochloride"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 84","initiation":"Initiation: 02/26/2015","start_date":" 02/26/2015","primary_txt":" Primary completion: 08/25/2021","primary_completion_date":" 08/25/2021","study_txt":" Completion: 07/31/2024","study_completion_date":" 07/31/2024","last_update_posted":"2024-06-07"},{"id":"4dcb8f8b-2695-4bef-a128-38e8217912be","acronym":"","url":"https://clinicaltrials.gov/study/NCT05177731","created_at":"2022-01-05T13:53:46.126Z","updated_at":"2024-07-02T16:34:36.990Z","phase":"Phase 3","brief_title":"Venetoclax + Decitabine vs. \"7+3\" Induction Chemotherapy in Young AML","source_id_and_acronym":"NCT05177731","lead_sponsor":"Chen Suning","biomarkers":" BCL2","pipe":"","alterations":" ","tags":["BCL2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • cytarabine • Xospata (gilteritinib) • decitabine • idarubicin hydrochloride"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 188","initiation":"Initiation: 03/01/2022","start_date":" 03/01/2022","primary_txt":" Primary completion: 02/28/2024","primary_completion_date":" 02/28/2024","study_txt":" Completion: 12/31/2024","study_completion_date":" 12/31/2024","last_update_posted":"2024-06-07"},{"id":"010331bf-33fb-4bf8-9f82-807ff99383fd","acronym":"","url":"https://clinicaltrials.gov/study/NCT04240002","created_at":"2021-04-20T18:53:44.636Z","updated_at":"2024-07-02T16:34:59.855Z","phase":"Phase 1/2","brief_title":"A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","source_id_and_acronym":"NCT04240002","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" FLT3","pipe":"","alterations":" ","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • fludarabine IV"],"overall_status":"Recruiting","enrollment":" Enrollment 97","initiation":"Initiation: 09/04/2020","start_date":" 09/04/2020","primary_txt":" Primary completion: 08/31/2027","primary_completion_date":" 08/31/2027","study_txt":" Completion: 08/31/2031","study_completion_date":" 08/31/2031","last_update_posted":"2024-05-31"},{"id":"f66040f9-40e2-41bd-8c69-4d4ef3afbdf1","acronym":"COMMODORE","url":"https://clinicaltrials.gov/study/NCT03182244","created_at":"2021-01-18T15:41:35.073Z","updated_at":"2024-07-02T16:35:01.009Z","phase":"Phase 3","brief_title":"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation","source_id_and_acronym":"NCT03182244 - COMMODORE","lead_sponsor":"Astellas Pharma Inc","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation • FLT3 D835 • FLT3 I836","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation • FLT3 D835 • FLT3 I836"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • etoposide IV • mitoxantrone • fludarabine IV"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 276","initiation":"Initiation: 01/15/2018","start_date":" 01/15/2018","primary_txt":" Primary completion: 12/25/2023","primary_completion_date":" 12/25/2023","study_txt":" Completion: 03/31/2026","study_completion_date":" 03/31/2026","last_update_posted":"2024-05-24"},{"id":"7b7c91a6-9486-4633-b3e2-ffef9fa008f4","acronym":"ADMIRAL","url":"https://clinicaltrials.gov/study/NCT02421939","created_at":"2021-01-17T17:23:13.438Z","updated_at":"2024-07-02T16:35:01.814Z","phase":"Phase 3","brief_title":"A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation","source_id_and_acronym":"NCT02421939 - ADMIRAL","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation • FLT3 D835 • FLT3 I836","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation • FLT3 D835 • FLT3 I836"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • azacitidine • etoposide IV • idarubicin hydrochloride • mitoxantrone • fludarabine IV"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 371","initiation":"Initiation: 10/20/2015","start_date":" 10/20/2015","primary_txt":" Primary completion: 09/17/2018","primary_completion_date":" 09/17/2018","study_txt":" Completion: 07/31/2024","study_completion_date":" 07/31/2024","last_update_posted":"2024-05-23"},{"id":"a1b1a802-1353-41c5-80f6-98719e12dcd4","acronym":"","url":"https://clinicaltrials.gov/study/NCT05520567","created_at":"2022-08-30T20:55:48.582Z","updated_at":"2024-07-02T16:35:01.630Z","phase":"Phase 1/2","brief_title":"A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia","source_id_and_acronym":"NCT05520567","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3 mutation • FLT3 D835 • FLT3 I836","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation • FLT3 D835 • FLT3 I836"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • Xospata (gilteritinib) • azacitidine"],"overall_status":"Recruiting","enrollment":" Enrollment 70","initiation":"Initiation: 01/27/2023","start_date":" 01/27/2023","primary_txt":" Primary completion: 07/31/2028","primary_completion_date":" 07/31/2028","study_txt":" Completion: 07/31/2028","study_completion_date":" 07/31/2028","last_update_posted":"2024-05-23"},{"id":"65ca92b9-439f-4528-a70b-00eb71d74d63","acronym":"GOSSAMER","url":"https://clinicaltrials.gov/study/NCT02927262","created_at":"2021-01-18T14:22:42.677Z","updated_at":"2024-07-02T16:35:14.396Z","phase":"Phase 2","brief_title":"A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission","source_id_and_acronym":"NCT02927262 - GOSSAMER","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib)"],"overall_status":"Completed","enrollment":" Enrollment 98","initiation":"Initiation: 01/10/2017","start_date":" 01/10/2017","primary_txt":" Primary completion: 05/25/2021","primary_completion_date":" 05/25/2021","study_txt":" Completion: 02/19/2024","study_completion_date":" 02/19/2024","last_update_posted":"2024-03-15"},{"id":"79eadd39-4040-4c6b-8888-5e8312df7fad","acronym":"MORPHO","url":"https://clinicaltrials.gov/study/NCT02997202","created_at":"2021-01-18T14:44:39.332Z","updated_at":"2024-07-02T16:35:14.662Z","phase":"Phase 3","brief_title":"A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)","source_id_and_acronym":"NCT02997202 - MORPHO","lead_sponsor":"Astellas Pharma Global Development, Inc.","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib)"],"overall_status":"Completed","enrollment":" Enrollment 356","initiation":"Initiation: 06/07/2017","start_date":" 06/07/2017","primary_txt":" Primary completion: 03/01/2023","primary_completion_date":" 03/01/2023","study_txt":" Completion: 05/09/2023","study_completion_date":" 05/09/2023","last_update_posted":"2024-03-15"},{"id":"7e180e9a-1ded-4851-881d-ffda6c389c90","acronym":"NCI-2019-04959","url":"https://clinicaltrials.gov/study/NCT04140487","created_at":"2021-01-18T20:12:57.909Z","updated_at":"2024-07-02T16:35:14.512Z","phase":"Phase 1/2","brief_title":"Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm","source_id_and_acronym":"NCT04140487 - NCI-2019-04959","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation • FLT3 D835","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation • FLT3 D835"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • Xospata (gilteritinib) • azacitidine"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 55","initiation":"Initiation: 12/17/2019","start_date":" 12/17/2019","primary_txt":" Primary completion: 09/01/2025","primary_completion_date":" 09/01/2025","study_txt":" Completion: 09/01/2025","study_completion_date":" 09/01/2025","last_update_posted":"2024-03-15"},{"id":"31616735-d05c-4ef1-aaeb-a7a574fd21c5","acronym":"PrE0905","url":"https://clinicaltrials.gov/study/NCT03836209","created_at":"2021-01-18T18:56:25.257Z","updated_at":"2025-02-25T15:26:01.620Z","phase":"Phase 2","brief_title":"Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia","source_id_and_acronym":"NCT03836209 - 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